Study of LM-102 in Patients With Advance Solid Tumors (NCT05008445) | Clinical Trial Compass
TerminatedPhase 1/2
Study of LM-102 in Patients With Advance Solid Tumors
Stopped: company adjusted strategy
China11 participantsStarted 2021-10-06
Plain-language summary
This is an open label Phase I/II trial of LM-102 injection, a recombinant humanized monoclonal antibody targeting Claudin 18.2 (CLDN18.2). It is being tested in advanced solid tumors including gastric cancer/gastroesophageal junction adenocarcinoma, Pancreatic Cancer, Biliary Tract Cancer, esophageal adenocarcinoma and ovarian mucous carcinoma.
Who can participate
Age range18 Years β 75 Years
SexALL
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Inclusion criteria
β. Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document prior to any procedure;
β. Aged between 18 to 75 years old, male or female when sign the Informed consent form (ICF);
β. Subjects who meet the criteria:
β. At least one evaluable lesion for phase I and one measurable lesion for phase II according to RECIST v1.1;
β. ECOG score 0-1;
β. Life expectancy β₯ 3 months;
β. Subjects must have the following organ and marrow function in laboratory tests within 7 days prior to the first dose;
β. Subjects who are able to well communicate with investigators as well as understand and adhere to the requirements of this study.
Exclusion criteria
β. Child-bearing potential female who have positive results in pregnancy test or are lactating;
β. Subjects who known to be allergic to the similar products or any of its excipients;
β. Exposure to any IMP, or participate in any other clinical trial within 21 days prior to 1st dosing of LM-102;
β. Subjects with anti-tumor treatment within 28 days prior to 1st dosing of LM-302, including radiotherapy, chemotherapy, biotherapy, endocrine therapy and immunotherapy, etc.
What they're measuring
1
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Timeframe: up to 21 days following first dose
2
Participant Safety as characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Timeframe: up to 31 days following last dose or other anti-cancer therapy
β. Subjects who have received surgical or interventional treatment within 28 days prior to 1st dosing LM-102, with the exception for tumor biopsy, puncture, etc.;
β. Subjects who have received the treatment targeting to CLDN18.2 or ADCs;
β. Use of any live vaccines (e.g., against infectious diseases such as influenza, varicella etc.) within 28 days prior to 1st dosing of LM-102;
β. Subjects with the history of interstitial lung disease or drug-induced interstitial lung disease/pneumonitis;